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Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

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ClinicalTrials.gov Identifier: NCT00455026
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : May 30, 2013
Sponsor:
Collaborator:
Biopharmica Limited
Information provided by:
Melbourne Health

Brief Summary:
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Condition or disease Intervention/treatment Phase
Depth of Anaesthesia Drug: remifentanil Phase 1

Detailed Description:
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
0 ng/ml target effect site concentration remifentanil
Drug: remifentanil
target effect site concentration during induction
Other Name: No other names
Active Comparator: 2
2 ng/ml target concentration remifentanil
Drug: remifentanil
target effect site concentration during induction
Other Name: No other names
Active Comparator: 3
4 ng/ml target effect site concentration remifentanil
Drug: remifentanil
target effect site concentration during induction
Other Name: No other names



Primary Outcome Measures :
  1. Prediction probability for prediction of anaesthetic endpoints [ Time Frame: During induction of anaesthesia ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia

Exclusion Criteria:

  • Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
  • Epilepsy or other EEG abnormality
  • Prescription or illicit drugs known to affect the EEG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455026


Locations
Australia, Victoria
Swinburne University
Hawthorn, Victoria, Australia, 3123
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Biopharmica Limited
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health

Responsible Party: David Breeze, Cortical Dynamics
ClinicalTrials.gov Identifier: NCT00455026     History of Changes
Other Study ID Numbers: 2005.236
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: March 2007

Additional relevant MeSH terms:
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents